NCT05627713

Clinical and Biological Aspects of the MONKEYPOX Disease

Description of the Kinetics of the Clinical and Biological Aspects of the Persons Consulting in the Framework of the Management of the MONKEYPOX Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Institut Pasteur · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Monkey pox virus (MPXV), of the genus Orthopoxvirus, regularly causes epidemics in endemic areas of central and western Africa. Since January 1, 2022, cases of Monkey pox have been reported to WHO by 96 Member States in the 6 WHO regions. As of 22 August 2022, a total of 41,664 laboratory-confirmed cases and 192 probable cases, including 12 deaths, have been reported to WHO. Since May 13, 2022, a high proportion of these cases have been reported from countries where monkey pox transmission had not previously been documented. For the first time, cases and sustained chains of transmission are being reported in countries without direct or immediate epidemiological links to areas in West or Central Africa (WHO 2022). France is one of the most affected countries with 2889 cases reported as of August 22, 2022. This situation led the WHO Director General to declare, on July 23, 2022, that the monkeypox epidemic currently affecting several countries constitutes a Public Health Emergency of International Concern. To address this epidemic, the WHO has recommended Post Exposure Vaccination (PEP) and Pre Exposure Vaccination (PrEP) for at risk groups with 2nd and 3rd generation vaccines. In France, the Haute Autorité de Santé (French National Authority for Health) recommended on May 20, 2022, vaccination for PEP and on July 7, 2022, for PrEP with a 3rd generation MVA-BN vaccine (Imvanex® or Jynneos®). The European Medicines Agency (EMA) has approved the use of Imvanex® on July 22, 2022 for immunization against MPXV. The objective of the present study is to describe the clinical, biological, virological, pathophysiological and immunological aspects in the short and medium term of persons vaccinated against and infected with MPXV.

Detailed description

Descriptive, prospective, monocentric, longitudinal study. Subjects will be enrolled during their consultation at CMIP as part of their curative or preventive management of MPXV disease. At the time of the appointment dedicated to vaccination or as part of the diagnosis of the infection, the clinician will explain the study in progress and will propose to the individual to participate if he/she is eligible. If so, after signing the informed consent form, the individual will be included in the study. The collection of socio-demographic, clinical and treatment data will be done on an eCRF at each study visit. Biological samples (blood and/or urine samples and/or swabs for viruses) will also be taken at each study visit. The samples will be used for the following biological analyses * serological analyses * sero-neutralization analysis by different techniques * cytometric analyses and biomarker measurements * virological analyses * genetic analysis.

Conditions

• Monkey Pox

Interventions

Type	Name	Description
OTHER	Blood sample collection	Blood sample collection between inclusion and 12 months after inclusion
OTHER	urine sample collection	urine sample collection at inclusion

Timeline

• Start date: 2022-12-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-11-28
• Last updated: 2023-12-19

Locations

1 site across 1 country: France